Hemostasis is a complex process which causes a bleeding process of a wound to stop. It refers to a multiple step process of repairing damaged blood vessels, including vasoconstriction, bleeding blockage by platelet aggregation, and a series of enzymatic reactions that ends in the formation of a fibrin protein fiber mesh that stabilizes the platelet plug to a clot.
In international patent application WO0222059A1, it is disclosed that bleeding wounds may be treated by applying pressure directly in the bleeding wound by applying a back pressure in a confined space around and in the wound. Substances or articles are inserted into the wound, and the wound may be enclosed with that substance or article encountered in the wound. The substance is for instance a hemostatic substance that is swelling on contact with blood and generates a pressure to stop or reduce the bleeding without the detrimental effects of a tourniquet. A wound dressing using this technology is provided that is either removable for a definitive treatment or biodegradable if not removed. When bleeding stops after insertion of such a device into a bleeding wound, the expanded device may be permitted to remain in the wound or may be removed. It is stated in WO0222059A1 that a decision whether to remove the expanded device or not is taken based on the need for access to the internal wound area for surgery, etc. Preferably the device is left in the patient unless the device needs to be removed from the wound for access to the internal wound area.
WO0222059A1 deals with devices for treatment of acute wounds, such as combat wounds before a surgical intervention.
An application for treatment of post-operative surgical confined wounds, that are cutaneously closed, is not foreseen in WO0222059A1. The devices and methods disclosed in WO0222059A1 are not suited for this purpose as there is for instance a desire that post-operative surgical confined wounds are not opened again unnecessarily.
In application U.S. 2008/0119785 an inflatable balloon for “wound track navigation and hemorrhage control” is disclosed. The balloon is to be inserted into a wound track to provide pressure to the surrounding wound tissue. No wound healing promoting is disclosed likewise modalities for the inhibition of tissue adhesion. The balloon may thus adhere to the wound and injure the patient upon removal of the device from the wound.
In application DE20320631U1, a medical device to be used in a healing process comprising flexible inflatable tube is disclosed. The balloon is also placed on the outside of the catheter, which may result in complications when removing the device from enclosed wounds. Neither wound treatment nor stopping of bleeding is disclosed in this document.
In application LU 90613A1 an intra- and peri-articular catheter is disclosed. A balloon is employed to apply pressure to artery walls to reduce intra- and peri-articular hemorrhages. The catheter can be used to drain wound exudates and surrounding the front end on the outside is the inflatable balloon used for applying pressure to the tissue. However due to the balloon being on the outside of the catheter removal from an enclosed wound would required reopening the wound, thus increasing the chances for infection.
In application WO 2009/120761 A1, an instrument for controlling bleeding at surgical sites is disclosed. An inflatable balloon is inflated to apply pressure to a wound. No fluid drainage is provided for neither is the use of further wound healing modalities. This is a device for very acute treatment. The balloon is spherical or toroidal and does not efficiently adapt to wound tissue topography. A wound healing process in a confined wound is not supported by this device.
In application U.S. 2002/0156495 A1, an apparatus for percutaneous sealing of blood vessel punctures is described. An inflatable balloon is used to seal primarily injured blood vessels and as such no wound drainage is provided for likewise initial wound healing.
In application U.S. 2005/0154416 A1, a therapeutic agent delivery system is disclosed. This device is designed to facilitate fluid release to the surrounding bodily tissue. The device is for very short term use in percutaneous transluminal angioplasty (PTA) applications and not suitable for stopping bleeding in confined wounds. A hydrophobic, biocompatible member with low friction is disclosed. No wound drainage devices or wound treatment are provided.
In application U.S. 2007/0243224 A1 describes methods and compositions for treating lesioned site of body vessels. Primarily nitric oxide (NO) is used to induce apoptosis of macrophages cells at lesioned site of a body vessel. A balloon is not described. A applying pressure to a wound similarly is not disclosed. NO is delivered to the vessel in gaseous form, as an aqueous solution, or from a stent. Moreover, NO in this context is used to reduce atherosclerotic plaque build up in contrast to NO being used to counter potential infections as with its use in the wound healing scenario.
In application U.S. 2008/0249464, a catheter having internal mechanisms to encourage balloon re-folding are disclosed. The device is to be used primarily for short-term angioplasty treatment procedures therefore the balloon used for these procedures is required to be rewrapped about the catheter shaft. The balloon therefore is on the outside of the device and is not designed to enter a sheath like structure. Furthermore no wound healing mechanisms are provided. There is no disclosure of a stent inside a balloon to support patency of the balloon.
In application WO 2009/153973 a rectal catheter and penetration enhancing system for enema drug delivery is provided. A vibrating inflatable balloon is employed in the intestines to enhance intestinal drug uptake. Neither wound healing is described nor wound drainage.
Hence, improved or alternative medical devices and procedures for treatment of post-operative surgical confined wounds would be advantageous, in particular allowing for increased flexibility, cost-effectiveness, and/or patient safety for said treatment would be advantageous.